MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. MLX 300W XENON LIGHTSOURCE; LIGHTING

Catalog Number	00MLX
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mlx 300w xenon lightsource (00mlx) was returned for evaluation: failure analysis: the returned 00mlx mlx 300w xenon lightsource was in used condition.The xenon lamp shield was displaced, which would allow excessive heat from the xenon lamp to overheat the headlight cable and cause the headlight cable to melt.Root cause analysis: the reported complaint was confirmed.Evaluation identified that the xenon lamp shield was displaced, which would allow excessive heat from the xenon lamp to overheat the headlight cable and cause the headlight cable to melt.This is most likely due to rough handling/environmental damage.
Event or Problem Description
This is 2 of 2 reports and is related to mfg number 3006697299-2025-00139.A facility reported that approximately 20 minutes into an ear, nose, and throat (ent) procedure, the mlx 300w xenon lightsource (00mlx) shut off, with the cord being described as hot or melting.Another light source was used to complete the procedure.There were no reported patient injuries, deaths, or surgical delays.The initial report did not indicate that 00mlx was overheating.Overheating of the 00mlx was discovered during the failure and root cause analysis of the product.

• Brand Name: MLX 300W XENON LIGHTSOURCE
• Common Device Name: LIGHTING
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 24495488
• Report Number: 3006697299-2026-00015
• Device Sequence Number: 21492285
• Product Code: FCW
• UDI-Device Identifier: 10381780168140
• UDI-Public: 10381780168140
• Combination Product (Y/N): N
• PMA/510(K) Number: 510K EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00MLX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown